Phase II Trial Evaluating the Efficacy and Tolerability of Aprepitant & Palonosetron for Prevention of Chemotherapy-Induced Nausea and Vomiting

Colorectal Cancer Clinical Trial

Official title:

A Multi-Center, Open-Label Trial to Evaluate the Efficacy and Tolerability of Aprepitant and Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Colorectal Cancer (CRC) Patients Receiving FOLFOX or FOLFIRI Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381862
• Other study ID #: CDR0000503649
• Secondary ID: OHSU-SOL-06006-L
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2006
• Last updated: February 9, 2016
• Start date: June 2006
• Est. completion date: July 2008

Study information

• Verified date: February 2016
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Aprepitant, palonosetron, and dexamethasone may help lessen or prevent nausea and vomiting in patients receiving chemotherapy.

PURPOSE: This phase II trial is studying how well giving aprepitant together with palonosetron and dexamethasone works in preventing nausea and vomiting caused by chemotherapy in patients receiving chemotherapy for metastatic colorectal cancer.

Description:

OBJECTIVES:

Primary

• Evaluate the efficacy, in terms of nausea and vomiting control, of aprepitant, palonosetron hydrochloride, and dexamethasone, in preventing chemotherapy-induced nausea and vomiting in patients receiving FOLFOX or FOLFIRI chemotherapy for metastatic colorectal cancer.

Secondary

• Assess the percentage of patients with no emesis and no rescue therapy when treated with aprepitant, palonosetron hydrochloride, and dexamethasone during repeated courses of FOLFOX or FOLFIRI chemotherapy.

• Assess the effects of aprepitant on nausea, appetite, taste changes (via visual analogue scale), nutritional intake, and mucositis in these patients.

• Assess the safety of this regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

Beginning 1 hour prior to the initiation of chemotherapy on day 1, patients receive oral aprepitant on days 1-3, oral dexamethasone on days 1-4, and palonosetron hydrochloride IV on day 1.

Nausea is assessed daily for up to 4 courses of chemotherapy.

Quality of life is assessed at baseline.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of colorectal cancer

• Metastatic disease

• Scheduled to receive 1 of the following chemotherapy regimens*:

• FOLFOX 4 (oxaliplatin, fluorouracil, leucovorin calcium)

• FOLFOX 6

• FOLFOX 7

• FOLFIRI (irinotecan hydrochloride, fluorouracil, leucovorin calcium) NOTE:

*Regimens may also include cetuximab or bevacizumab

• No emesis and no requirement for antiemetic agents within 48 hours prior to beginning chemotherapy

• Single-agent benzodiazepines as a hypnotic allowed

• No chronic nausea

PATIENT CHARACTERISTICS:

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Life expectancy > 4 months

• White Blood Cell(WBC)count > 3,000/mm^³

• Absolute neutrophil count (ANC) > 1,500/mm^³

• Platelet count > 100,000/mm^³

• Bilirubin = 2.5 times upper limit of normal (ULN) (< 5 times ULN if liver metastases present)

• Creatinine = 1.5 times ULN

• Aspartate aminotransferase(AST) or Alanine aminotransferase (ALT) = 2.5 times ULN (< 5 times ULN if liver metastases present)

• Able to swallow tablets and capsules

• No known sensitivity to aprepitant, palonosetron hydrochloride, or dexamethasone

• Not pregnant or nursing

• Negative pregnancy test

• No history of consuming = 5 alcoholic drinks/day within the past year

• No concurrent illness requiring systemic corticosteroids other than planned dexamethasone during study treatment

• No clinical signs of active systemic infection involving the gastrointestinal tract

• No active bowel obstruction

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior chemotherapy > Hesketh level 3

• Prior fluorouracil with or without leucovorin calcium or capecitabine allowed

• At least 30 days since prior investigational drugs

• At least 14 days since prior neurokinin-1 antagonists

• Concurrent hydrocortisone at physiologic replacement doses (= 30 mg/day) allowed

• No concurrent chronic antiemetic agents

• Concurrent hypnotics allowed

• Concurrent rescue antiemetics allowed

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Nausea
• Nausea and Vomiting
• Vomiting

Intervention

Drug:
• aprepitant
Aprepitant 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle
• dexamethasone
Dexamethasone 12 mg PO on 1st day of study drug and 8 mg PO on days 2-4
• fluorouracil
as per institutional standard of care
• irinotecan hydrochloride
as per institutional standard of care
• leucovorin calcium
as per institutional standard of care
• oxaliplatin
as per institutional standard of care
• palonosetron hydrochloride
Palonosetron 0.25 mg IV push on day 1 only.

Procedure:
• quality-of-life assessment
baseline

Locations

Country	Name	City	State
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Kaiser Permanente	Hilo	Hawaii
United States	Kansas City Cancer Center	Kansas City	Missouri
United States	OHSU Knight Cancer Institute	Portland	Oregon
United States	St. Josephs/Cander Hospital	Savannah	Georgia
United States	Texas A & M university / Scott and White Clinic	Temple	Texas

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With no Emesis and no Rescue Therapy Within 5 Days of Receiving FOLFOX and FOLFIRI in the First Cycle of Chemotherapy.		Up to 24 weeks	No
Secondary	Percentage of Patients With no Emesis and no Rescue Therapy During Repeated Courses of Chemotherapy		Duration of time that the patient is on study	No
Secondary	Effects of Aprepitant on Nausea, Appetite, Taste Changes, (Via Visual Analogue Scale [VAS]), Nutritional Intake, and Mucositis in the Colorectal Cancer (CRC) Population.		Duration of time the patient is on study	No
Secondary	To Assess the Safety of the Combination of Aprepitant, Palonosetron, and Dexamethasone in the Colorectal Cancer(CRC) Population in the First and Subsequent Cycles of Chemotherapy.		Duration of time patient is on study	Yes
Secondary	Percentage of Patients With no Emesis and no Rescue Therapy Within 5 Days of the First Course of Chemotherapy		within 5 days of chemotherapy	No